FDA.reportPublic FDA data

ESZOPICLONE

Product NDC
61919-033
11-digit product format
619190033
Labeler code
61919
Product ID
61919-033_4c47d883-5220-4dd2-e063-6394a90af7a4
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ESZOPICLONE
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
DIRECT RX
Application
ANDA202929
Marketing category
ANDA
Marketing start
2017-02-13
Substance
ESZOPICLONE
Active strength
2 mg/1
DEA schedule
CIV
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
ESZOPICLONE
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ESZOPICLONE2 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiUZX80K71OE
Rxcui485442

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
f65008ed-f925-2246-581a-e6a3201df7e4Product name520250107

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
61919-033-102025-01-30C16284748780-12cef2736-7d34-d83d-e063-dadaa90ab31fESZOPICLONE C-IV
61919-033-302025-01-30C16284748780-12cef2736-7d34-d83d-e063-dadaa90ab31fESZOPICLONE C-IV

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61919-033-10ESZOPICLONE10 in 1 BOTTLETABLET, FILM COATED105
61919-033-30ESZOPICLONE30 in 1 BOTTLETABLET, FILM COATED305
61919-033-60ESZOPICLONE60 in 1 BOTTLETABLET, FILM COATED605

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
61919-033-10EA - Each61919-0332a4a7256-ecad-4922-8856-3de4f510aab512022-05-04
61919-033-30EA - Each61919-03384ffeb4f-8ec0-4bb3-a010-8512d96aefdf12017-04-05
61919-033-60EA - Each61919-0332ff2fccb-d8ce-4232-a7f2-5e37c850f7fe12026-04-20

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61919-033ESZOPICLONE TABLET, FILM COATED [DIRECT RX]4Current NDC, Legacy NDC, 3 package rows20230331_486b760b-7fea-306b-e054-00144ff8d46c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
485442eszopiclone 2 MG Oral TabletPSN486b760b-7fea-306b-e054-00144ff8d46c5
485442eszopiclone 2 MG Oral TabletSCD486b760b-7fea-306b-e054-00144ff8d46c5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
61919-033-106191900331010 TABLET, FILM COATED in 1 BOTTLE (61919-033-10) 2017-02-130000-00-00NoNoCurrent
61919-033-306191900333030 TABLET, FILM COATED in 1 BOTTLE (61919-033-30) 2017-02-130000-00-00NoNoCurrent
61919-033-606191900336060 TABLET, FILM COATED in 1 BOTTLE (61919-033-60) 2017-02-13NoNoCurrent